Youngjin Mirtazapine Tablets 30 mg (Mirtazapine)

Adult dosage

The therapeutic dose of this medicine should be adjusted according to the patient's clinical status, and the lowest effective dose possible should be administered. 1. Adults The initial dose of mirtazapine is 15mg once daily, and the dose may need to be increased until an adequate clinical response is achieved. The usual effective daily dose is 15~45 mg of this medicine. 2. Dosage in special populations 1) Patients with renal impairment Clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); therefore, caution is required when prescribing it. 2) Patients with hepatic impairment Clearance of this medicine may be reduced in patients with hepatic impairment; therefore, caution is required when prescribing it. In particular, this medicine has not been studied in patients with severe hepatic impairment, so caution is required when prescribing it. 3) Older adults The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe effect. 3. Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medicine. 4. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. For patients who require more urgent treatment of a psychiatric condition, including hospitalization or other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after starting linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with methylene blue administered by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses. The half-life of this medicine is 20∼40 hours, so once-daily administration is sufficient. If possible, take it at a consistent time in the evening before bedtime. The total daily dose of this medicine may also be divided into two equal doses, taken once in the morning and once in the evening. To allow sufficient time to evaluate the therapeutic response to the dose of this medicine, do not change the dose at intervals of less than 1～2 weeks. With treatment at an appropriate dose, a therapeutic effect occurs within 2～4 weeks. If the response is inadequate, the dose may be increased to the maximum dose. If there is no response after continuing treatment for an additional 2～4 weeks, discontinue treatment. Treatment should be continued for at least 4∼6 months, until the patient's symptoms have completely resolved. Thereafter, gradual discontinuation is recommended to avoid withdrawal symptoms. This medicine is taken orally. Swallow it with water without chewing.

Children's dosage

Pediatric patients and adolescents under 18 years of age: Because efficacy was not demonstrated in two short-term clinical trials and there are safety concerns, this drug should not be used in pediatric patients and adolescents under 18 years of age.

This medication is primarily used as an antidepressant for the treatment of depression. It may particularly increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so when administering to patients in this age group, doctors must exercise caution, and patients and families must closely monitor for any suicidal tendencies or behavioral changes. Rarely, serious side effects such as agranulocytosis, which is a rapid decrease in white blood cells, may occur, so if symptoms of fever or infection develop, a doctor should be notified immediately. Patients with impaired liver or kidney function, heart disease, or diabetes need to be especially cautious about taking this medication. Common side effects include drowsiness, dizziness, increased appetite, and weight gain; therefore, it is advisable to avoid operating vehicles or machinery during the initial phase of taking this medication. Since there is a possibility of interaction with other drugs, it is essential to inform a doctor or pharmacist about any other medications being taken, especially that MAO inhibitors should not be taken concurrently. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and it should not be used in children or adolescents under 18 years old. Overdosing may result in severe side effects; therefore, prescribed dosages must be strictly adhered to, and if an overdose is suspected, immediate medical attention should be sought. Lastly, this medication must be kept out of reach of children, and it is crucial to consult medical staff immediately if any abnormal symptoms occur during treatment.

• Drowsiness
• nausea
• increased appetite
• weight gain
• dizziness
• weakness
• flu-like syndrome
• lower back pain
• dry mouth
• constipation

This medication should be stored in a tightly sealed container protected from light and moisture, at a temperature between 2°C and 30°C. This storage condition helps maintain the efficacy of the medication.

Appearance

reddish-brown oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle